Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Medical Director M-SERM - And lead our efforts in medical safety evaluation and risk management.

What You’ll Do:
- Maintain understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
- Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to CRG’s corporate policies and SOPs/WPDs.
- Provide medical consultation to team members and answer all project/study related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provide safety reporting training on assigned projects/studies, as requested.
- Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous,



literature, etc) as contracted.
- Provide medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
- Perform data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
- Assist in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
- Manage signal detection activities, scientifically review periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities.

Education and Experience:

MD or equivalent required. History of an active medical license is highly preferred. Candidates should have at least on

📌 Medical Director M-SERM (Colombia)
🏢 ThermoFisher Scientific
📍 Colombia